9 January 2025 Intelligence provider Clarivate has released the 12th annual Drugs to Watch report, a guide to the therapies poised to redefine the future of healthcare.
German pharma major Bayer today announced top-line results of the Phase III study OASIS 4 investigating elinzanetant as non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or in women at high risk of developing breast cancer. 9 January 2025
Intelligence provider Clarivate has released the 12th annual Drugs to Watch report, a guide to the therapies poised to redefine the future of healthcare. 9 January 2025
UK headquartered Verdiva Bio Limited today announced its launch as a clinical-stage biopharmaceutical company focused on developing innovative therapies for obesity and other cardiometabolic disorders. 9 January 2025
Italy-based Newron Pharmaceuticals (SIX: NWRN, XETRA: NP5), a biopharma developing therapies for diseases of the central and peripheral nervous system, has announced a deal with South Korea’s Myung In Pharm. 9 January 2025
German family-owned pain focused drugmaker Grünenthal announced today that Prof Dr Uli Brödl will assume the role of chief scientific officer (CSO) and a member of the corporate executive board, effective February 1, 2025. 9 January 2025
Insilico Medicine, a biotechnology firm specializing in artificial intelligence-powered drug discovery, has raised over $100 million in a series E funding round. 8 January 2025
Calico Life Sciences, a biotech founded by Alphabet and Arthur Levinson focused on the biology of aging and age-related diseases, has announced a setback. 8 January 2025
Denmark’s Novo Nordisk and Valo Health today announced they have entered into an expanded agreement to discover and develop novel treatments for obesity, type 2 diabetes, and cardiovascular disease based on Valo’s extensive human dataset and computation powered by artificial intelligence (AI). 8 January 2025
Antag Therapeutics, a Denmark-based biopharma developing novel treatments for obesity, has announced the appointment of Joerg Moeller as chief executive officer, effective immediately. 8 January 2025
Metsera today announced positive data from a 12-week Phase IIa clinical trial of MET-097i, its potential once-monthly, ultra-long acting, subcutaneously injectable, fully-biased, GLP-1 receptor agonist (RA). 7 January 2025
Central nervous system (CNS) specialist Neuraxpharm Group has acquired Provigil (modafinil) and Nuvigil (armodafinil), both of which are indicated for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. 7 January 2025
Japan-based FUSO Pharmaceutical Industries and Australia’s Dimerix Limited have entered into an exclusive development and license agreement for the development and commercialization of Dimerix’ Phase III drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in Japan. 7 January 2025
The heart failure market is projected to grow at a compound annual growth rate of 9.6% over the next decade, increasing from $13.5 billion in 2022 to $33.7 billion in 2032 across seven major markets, according to a report from analytics firm GlobalData. 7 January 2025
A late-stage trial failure has dented Denali Therapeutics stock, with an announcement Monday revealing the HEALEY ALS study missed all endpoints. 7 January 2025
Unquestionably, US drugmaker Vertex Pharmaceuticals is the dominant drug developer in the cystic fibrosis (CF) space.
How has the company achieved this — on the R&D and patient access side — and what is the company doing to help the remaining patients? Vertex’s Andrew Wilfin, Senior Country Medical Director, UK and Ireland, took part in a Q&A with The Pharma Letter to reveal all. 7 January 2025
The US Food and Drug Administration (FDA) issued a draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s safety, effectiveness or quality. 7 January 2025
Sentynl Therapeutics, wholly owned by Zydus Lifesciences, has announced that the US Food and Drug Administration has accepted its New Drug Application for CUTX-101, a potential first treatment for Menkes disease. The application has been granted priority review, with a target action date set for June 30, 2025. 7 January 2025
rug Administration (FDA) approved an update to the US Prescribing Information (USPI) for Pyrukynd (mitapivat) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, Agios Pharmaceutical revealed in a Security and Exchange Commission (SEC) notice. 7 January 2025
After eight years of follow-up, Eli Lilly has revealed that a statistically -significant overall survival (OS) improvement was not reached for patients in the MONARCH 3 trial. 7 December 2023
Shares of Cerevel Therapeutics shot up almost 16% to $42.75 in pre-market trading this morning, after it was revealed late yesterday it had received a takeover offer from US pharma major AbbVie. 7 December 2023
The US Food and Drug Administration (FDA) has extended by three months the review period of its supplemental new drug application (sNDA) requesting approval of Xhance (fluticasone propionate) as a treatment for chronic rhinosinusitis. 7 December 2023
The US Food and Drug Administration (FDA) has approved Fabhalta (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). 6 December 2023
Swiss pharma giant Novartis is consolidating its commitment to radioligand therapies with the establishment of a second production site in China. 6 December 2023
Aqemia, a next-gen French pharmatech company leveraging artificial intelligence and quantum physics, has entered into a multi-year research collaboration with French pharma major Sanofi. 6 December 2023
American healthcare giant Johnson & Johnson has undertaken an in-depth business review, publishing plans which include the launch of 20 new products by the end of the decade. 6 December 2023
Neurocrine Biosciences yesterday revealed it has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for crinecerfont in congenital adrenal hyperplasia. 6 December 2023
French drugmaker Sanofi is experiencing serious problems in Russia, as due to logistical problems, the company almost stopped exporting insulin from its Russian plant to the European Union. 6 December 2023
USA-based ophthalmic diseases specialist EyePoint Pharmaceuticals saw its shares leap as much as 212% yesterday, after it announced positive top-line results of its Phase II DAVIO 2 trial of EYP-1901. 5 December 2023
Johnson & Johnson’s TAR-200 has been granted Breakthrough Therapy designation (BTD) to potentially treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC), who are ineligible for or elected not to undergo radical cystectomy. 5 December 2023
French independent pharma major Servier today announced the appointment of Nicolas Garnier as chief patient officer, effective from December 4. 5 December 2023
Privately-held Californian company Alto Neuroscience has announced encouraging results from its Phase IIa study of ALTO-300 at the 62nd Annual Meeting of the American College of Neuropsychopharmacology (ACNP). 5 December 2023
Industry has renewed its criticism of the UK government after the publication of new terms for the statutory scheme for branded medicines. 5 December 2023
Spanish drugmaker PharmaMar has announced that its licensing partner, Luye Pharma Group, has received marketing approval for Zepzelca (lurbinectedin) in Macao. 5 December 2023
Hungarian drugmaker Gedeon Richter has expanded its partnership with Mithra Therapeutics with a deal to develop and commercialize the first estetrol-based combined oral contraceptive in China. 5 December 2023
In the latest move in the USA for rights to contraceptives and abortion drugs, on Monday, the Reproductive Rights Task Force (RRTF) provided a briefing to Attorney General Merrick Garland and Task Force Chair Associate Attorney General Vanita Gupta on the Department of Justice’s (DoJ) work to protect reproductive freedom under federal law. 5 December 2023
Israeli biotech RedHill Biopharma has announced new funding of around $5 million, which will be directed towards evaluation of COVID-19 treatment RHB-107, also known as upamostat. 4 December 2023
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